Atlas FDA

GOL

21 FDA 510(k) clearances · Product code

77 daysmedian time to decision
130 days90th percentile
21clearances measured

FDA profile

Official device name
Antigen, Ha (Including Ha Control), Rubella
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3510
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2009: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
RUBELLA ANTIBODY FLUOROIMMUNOASSAY (K841174)Intl. Diagnostic Technology1984-06-07
RUBAQUICK DIAGNOSTIC KIT (K834032)Abbott Laboratories1984-04-17
RUBELLA ANTIBODIES TEST REAGENTS (K810309)Calbiochem-Behring Corp.1981-03-11
RUBELISA IGM TEST KIT (K802508)M.A. Bioproducts1980-12-18
RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (K802102)Calbiochem-Behring Corp.1980-12-18
EIA RUBELLA-G (K802339)Beckman Instruments, Inc.1980-12-18
GAMMA COAT(125 I) RUBELLA ANTIBODY (K801667)Clinical Assays, Inc.1980-10-23
ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (K801098)Flow Laboratories, Inc.1980-09-16
ANTIGEN CONTROL CELLS (K801507)Ortho Diagnostics, Inc.1980-08-20
RUBELLA BIO-BEAD TITRATION KIT (K800789)Litton Bionetics1980-06-30
MACRO-VUE RUBELLA CARD TEST (K800797)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-06-20
FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD (K792249)Intl. Diagnostic Technology1980-01-23
RUBELLA BIO-BEAD SCREEN KIT (K791610)Litton Bionetics1979-11-13
RUBAZYME (K790976)Abbott Laboratories1979-08-16
CORDIA T (K790212)Cordis Corp.1979-04-12
CORDIA R (K780885)Cordis Corp.1979-01-17
RUBA-NOST TEST KITS (K771796)Behring Diagnostics, Inc.1977-10-18
MEASLES-FA LABELLED (8-441 RF) (K770805)Flow Laboratories, Inc.1977-05-20
MEASLES-FA LABELED PRESERUM (8-441 RNF) (K770809)Flow Laboratories, Inc.1977-05-20
HERPESIVIRUS TEST (TYPE L & 2) (K770092)Microbiological Research Corp.1977-03-01
TEST FOR DETECTION OF ANTIRUBELLA ANTIB (K760889)Abbott Laboratories1976-11-16

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Every clearance here is in the API, with alerts when new ones post.